Early Screening and Treatment of Heart Complication in Sickle Cell Disease (NCT07023666) | Clinical Trial Compass
RecruitingPhase 2
Early Screening and Treatment of Heart Complication in Sickle Cell Disease
United States100 participantsStarted 2025-10-07
Plain-language summary
This study tests whether early heart screening and treatment for iron overload in subjects with sickle cell disease can prevent heart problems and reduce hospitalizations.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* At least 18 years of age
* Diagnosis of sickle cell disease (any genotype)
* Serum ferritin levels ≥ 400 ng/mL (up to 80 patients), or less than 400 ng/mL in those who have cardiac symptoms including shortness of breath and lower extremity edema (up to 20 patients)
* Willingness to undergo regular imaging (echocardiograms, ECG, cardiac MRI)
* ECOG performance status of 0-1
* Able to read, understand and provide written informed consent
* Deemed appropriate for participation by the treating physician
Exclusion Criteria:
* Unable to schedule and required follow-up visits
* Medical comorbidities including:
* Known heart failure
* Unstable angina
* Uncontrolled dysrhythmias
* Acute pulmonary embolism
* Active infection or severe comorbid conditions that in the view of the investigator would limit participation
* History of hypersensitivity or contraindication to chelation therapy
* Severe renal or hepatic impairment
* Pregnancy of breastfeeding
What they're measuring
1
Incidence of Hospitalization for Sickle Cell Disease Related Complications